Alpha-1 Research Registry Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Establish the Alpha-1 Research Registry using REDCap
研究概览
简要总结
The Alpha-1 Research Registry is a confidential database made up of individuals diagnosed with Alpha-1 Antitrypsin Deficiency (Alpha-1) and individuals identified as Alpha-1 carriers. The Registry was established to facilitate research initiatives and promote the development of improved treatments and a cure for Alpha-1.
详细描述
The purpose and goal of the Alpha-1 Research Registry (Registry, or group of patients) will be to obtain uniform, longitudinal (over the course of time), complete and accurate data that can be organized, and made available for the public to query. The collective number of Registry members enables investigators to enroll sufficient subjects to carry out their studies. The community benefits from having more research and potential therapies performed in their disease. Regular updates from patients will give objective data-points to measure the progression of disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Alpha-1 Antitrypsin Deficiency (PiZZ, PiZNull, PiSZ etc.)
- •Alpha-1 carriers (PiMZ, PiMS etc.)
排除标准
- •Failure to provide informed consent
- •Normal healthy individuals (MM)
结局指标
主要结局
Establish the Alpha-1 Research Registry using REDCap
时间窗: 2 years
To gather accurate patient data for longitudinal prospective follow up/analysis of Alpha-1 progression.
Establish the Alpha-1 Research Registry using REDCap
时间窗: 8 years
To gather accurate patient data for longitudinal prospective follow up/analysis of Alpha-1 progression.
次要结局
未报告次要终点